Cleared Traditional

K926393 - VIDAS THYROXINE (T4) ASSAY (T4)

K926393 is an FDA 510(k) clearance for VIDAS THYROXINE (T4) ASSAY (T4), manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K926393 · Biomerieux Vitek, Inc. · Chemistry device
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May 1993
Decision
143d
Days
Class 2
Risk

K926393 is an FDA 510(k) clearance for the VIDAS THYROXINE (T4) ASSAY (T4). Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 13, 1993 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

FDA 510(k) Submission Details - K926393

510(k) Number K926393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date May 13, 1993
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K926393.
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · Microgenics Corp. · Mar 1994
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc. · Jan 1994
ACCESS(R) THYROXINE ASSAY
K926475 · Bio-Rad Laboratories, Inc. · Jun 1993
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · Medix Biotech, Inc. · Mar 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991